RecruitingPhase 2NCT06130059

Efficacy of LoDoCo in Improving Exercise Capacity Among Patients With HFpEF and Inflammation

Pilot Study to Evaluate the Efficacy of Low Dose Colchicine (LoDoCo ®) to Improve Exercise Capacity Among Patients With Chronic Stable HFpEF and Systemic Inflammation


Sponsor

University of Texas Southwestern Medical Center

Enrollment

60 participants

Start Date

Apr 24, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this research study is to determine the effectiveness of low dose colchicine (LoDoCo) on measures of exercise capacity, physical function, frailty, and quality of life, among patients with heart failure with chronic stable preserved ejection fraction (HFpEF) and systemic inflammation. The use of LoDoCo in this study is considered investigational as it has not been approved by the Food and Drug Administration (FDA) for the treatment of exercise capacity in patients with HFpEF. Participants will undergo a 1-day screening that includes a blood draw and physical examination. If deemed eligible for the study, participants will undergo a baseline visit within 2 weeks of screening visit that includes physical examination, exercise testing, echocardiography and completion of quality-of-life surveys. Participants will also be randomized at this visit (randomly assigned to a group) to receive either LoDoCo or placebo (inactive substance) for 3 months. Participants will be called back at 3 months for repeat physical examination, blood draws, echocardiography, exercise testing and completion of quality-of-life surveys. Each visit will take about 3 hours. Total study duration is about 3 months.


Eligibility

Min Age: 50 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether a low-dose anti-inflammatory drug called colchicine (LoDoCo) can help people with heart failure with preserved ejection fraction (HFpEF) exercise better. HFpEF is a type of heart failure where the heart pumps normally but the heart muscle is too stiff, making it hard to be active. Researchers believe that reducing inflammation may help improve exercise capacity. **You may be eligible if...** - You are 50 years or older - You have been diagnosed with HFpEF (a type of heart failure where your heart pumps normally but is stiff) - You have elevated inflammation markers in your blood (high hs-CRP) - You are able to walk and do an exercise test on a stationary bike or treadmill - Your heart failure medications have been stable for at least 1 month **You may NOT be eligible if...** - You are pregnant, breastfeeding, or planning pregnancy - Your kidneys are severely impaired - You have severe heart valve disease needing surgery - Your liver enzymes are significantly elevated - You are not able to perform an exercise test - Your life expectancy is less than 1 year Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGLow Dose Colchicine

Colchicine has been demonstrated to improve cardiovascular outcomes among patients with cardiovascular disease. In the COLCOT trial, the use of low-dose colchicine resulted in a reduction of major adverse cardiovascular events among participants with recent MI. The trial demonstrated the utility of anti-inflammatory therapies in improving cardiovascular outcomes. Colchicine has been widely used for decades and its safety profile is well established.

DRUGPlacebo

Placebo


Locations(1)

UT Southwestern Medical Center

Dallas, Texas, United States

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NCT06130059


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